Tapentadol PR & IR, V3.0 (KF 44) for low back pain (Study 3)

• Research type

  Research Study

• Full title

  An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with uncontrolled severe chronic nociceptive, mixed or neuropathic low back pain taking either WHO Step I or Step II analgesics or no regular analgesics.

• IRAS ID

  21836

• Eudract number

  2009-010427-12

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  This is a 13 week, phase IIIb study and 180 subjects with severe low back pain will be enrolled in this multicentre, multinational, open label study. The main objective is to evaluate the effectiveness, tolerability and safety of tapentadol hydrochloride prolonged release (PR) in subjects with severe chronic nociceptive (pain/discomfort from sprains, bruises, inflammation, pain described as aching/ throbbing, goes away over time), mixed or neuropathic (often nerve pain, described as burning/stabbing, is often chronic) low back pain. Secondary objectives are to also demonstrate that tapentadol hydrochloride PR produces a better analgesia (pain relief) than current analgesics used (Step I, II or III)Analgesics are grouped according to the World Health Organisation (WHO) classification as Step I, Step II and Step III. Step I analgesics (non-opioids) include nonsteroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, & paracetamol.Step II analgesics (combination opioid/non-opioids & weak opioids) include tramadol, codeine and combination products of oxycodone, tramadol & codeine Step III analgesics include morphine, oxycodone & transdermal fentanyl. Tapentadol has favourable side effects and its use may reduce the need for other medications, e.g. anti-emetics (help prevent sickness) & laxatives routinely prescribed for the treatment of side effects typically produced by opioids. Male or female participants who are at least 18 years of age with a diagnosis of chronic low back pain (chronic pain defined as pain lasting for at least 3 months) and whose pain requires strong analgesia/pain relief (defined as WHO III analgesia) are eligible for this study. This is one of four studies looking at tapentadol hydrochloride PR (Prolonged Release) and IR (Immediate Release) as an alternative WHO Step III analgesic in two different pain models (low back pain and osteoarthritis of the knee).

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/46

• Date of REC Opinion

  14 Oct 2009

• REC opinion

  Further Information Favourable Opinion